CDC/IDSA COVID-19 Clinician Call - June 5, 2021
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CDC/IDSA COVID-19 Clinician Call • 68th in a series of weekly calls, initiated by CDC as a forum for information sharing among frontline clinicians caring for patients with COVID-19 June 5, 2021 • The views and opinions expressed here are those of the presenters and do not necessarily reflect the Welcome & Introduction official policy or position of the CDC or Susanna Visser, DrPH, MS IDSA. Involvement of CDC and IDSA should not be Senior Advisor, Policy and Partnerships Team viewed as endorsement of any entity or individual HSWS Task Force COVID-19 Response involved. Associate Director for Policy & Extramural Program Division of Vector-Borne Diseases • This webinar is being recorded and can be found National Center for Emerging and Zoonotic Infectious online at www.idsociety.org/cliniciancalls. Diseases Centers for Disease Control and Prevention 1
Debbie Dowell, MD, MPH, CAPT, USPHS Deputy Chief Medical Officer COVID-19 Response Centers for Disease Control and Prevention Emilia (Emily) Koumans, MD, MPH Clinical Disease and Health Systems Team Lead COVID-19 Response Centers for Disease Control and Prevention TODAY’S TOPIC: Lilian Abbo, MD, FIDSA Chief Infection Prevention and Antimicrobial Stewardship Update on Breakthrough Jackson Health System Professor of Infectious Diseases University of Miami Miller School of Medicine Infections Shweta Anjan, MD Assistant Professor of Clinical Medicine Division of Infectious Diseases University of Miami Miller School of Medicine David Andrews, MD Associate Professor of Clinical Pathology University of Miami Miller School of Medicine CLIA Laboratory Director, Jackson Memorial Hospital 2
CDC Science Brief: COVID-19 Vaccines and Vaccination Debbie Dowell, MD, MPH Deputy Chief Medical Officer, COVID-19 Response CDC/Infectious Diseases Society of America Clinician Call June 5, 2021 cdc.gov/coronavirus
CDC Science Brief: COVID-19 Vaccines and Vaccination ▪ Available at www.cdc.gov/coronavirus/2019-ncov/science/science- briefs/fully-vaccinated-people.html ▪ Purpose: to summarize the evidence supporting CDC’s Interim Public Health Recommendations for Fully Vaccinated People ▪ Last updated April 2, 2021 – Guidance update released April 27 – Guidance update released May 13 – Substantial increase in the evidence base
Summary of Major Updates to Science Brief ▪ 17 new studies showing effectiveness of COVID-19 vaccination – First real-world study of Johnson & Johnson’s Janssen vaccine ▪ 9 new studies supporting reductions in transmission of SARS-CoV-2 by vaccinated people who become infected – 3 new studies of vaccine effectiveness against asymptomatic infection – 4 new studies showing reduced viral load among infected vaccinated people – 2 new studies directly documenting reduced transmission ▪ More data on effectiveness of mRNA vaccines against variants of concern ▪ Streamlined content to focus on robust body of vaccine evidence – Created separate brief for evidence supporting travel recommendations
Summary of Current Evidence (1st of 2 summary slides) ▪ Effectiveness of COVID-19 vaccines ≥7 days post-vaccination – mRNA vaccines 85%-99% effective against symptomatic disease • One study from Denmark estimating 64% effectiveness in long- term care residents – mRNA vaccines 92%-98% effective against severe disease and 87%- 97% against hospitalization – J&J/Janssen vaccine 77% effective against symptomatic disease
Summary of Current Evidence (2nd of 2 summary slides) ▪ Effectiveness of COVID-19 vaccines against transmission – mRNA vaccines 65%-92% effective against asymptomatic infection – Transmission risk to household contacts approximately halved by vaccination ▪ Effectiveness of COVID-19 vaccines against variants – mRNA vaccines: >85% overall when B.1.1.7 prevalent – Pfizer-BioNTech: 90% against B.1.1.7; 75% against B.1.351 – J&J/Janssen: reduced VE when B.1.351 prevalent but ≥73% vs. severe disease
What We’re Still Learning ▪ Effectiveness of vaccination among immunosuppressed populations – Reduced immunogenicity of vaccination observed among several groups ▪ Duration of immunity ▪ Level of population immunity needed for community protection ▪ Real-world effectiveness of Johnson & Johnson’s Janssen vaccine on outcomes including severe disease, hospitalization and death. ▪ More about effectiveness against viral transmission and infection with variants of concern
Key Points ▪ All COVID-19 vaccines currently authorized in the United States are effective against COVID-19, including serious outcomes like severe disease, hospitalization, and death. ▪ A growing body of evidence indicates that people fully vaccinated with an mRNA vaccine are less likely to have asymptomatic infection or to transmit SARS-CoV-2 to others. Studies are underway to learn more about the benefits of Johnson & Johnson/Janssen vaccine. ▪ Available evidence suggests the currently authorized mRNA COVID-19 vaccines provide protection against a variety of strains, including B.1.1.7 and B.1.351; other vaccines show reduced efficacy against B.1.351 but may still protect against severe disease.
For more information, contact CDC 1-800-CDC-INFO (232-4636) TTY: 1-888-232-6348 www.cdc.gov The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
The Miami Experience at Jackson Health System Variants, Vaccinations and COVID-19 Breakthrough Infections Lilian Abbo, M.D., FIDSA Chief Infection Prevention & Antimicrobial Stewardship Jackson Health System Professor of Infectious Diseases University of Miami Miller School of Medicine
Disclosure • No conflicts of interest to disclose
JMH licensed 1550 beds 270 ICU beds 2 Community Hospitals 2 Long Term Care Facilities 12,000 employees 500 University of Miami Faculty 4 Miami-Dade Corrections/ Jails
What about our Healthcare workers? As of June 3, 2021 7401 vaccinated 19 vaccine breakthrough cases identified (rate 0.25%)
Case Presentation • 61-year-old male • Past Medical history: HTN, Nephrotic Syndrome, ESRD on hemodialysis since 6/2020 • Received 2 doses of mRNA vaccine (Pfizer-BioNTech) 78 days prior • Presented with fever, cough, dyspnea, nausea, and diarrhea for 3 days • No prior COVID-19 infection and no severe reactions to the vaccine • On physical exam: patient was in distress, with decreased breath sounds bilaterally 16
Labs and Imaging WBC 19.9 10(3)/mcL D-dimer: 1.57 CRP: 8.2 ANC: 17.8 Platelets: 235 mcg/ml mg/dl ALC: 1.2 Blood Ferritin: 2094 LDH: 1042 Troponin: Cultures: ng/ml unit/L 0.027 ng/ml Negative
Hospital Course Day of Hospital admission: COVID-19 78 days Antibodies from second Detected dose, Total: 156 Day 6 – 8, On 4 L/min of O2 IgG: 22.18 4-5 L via NC Day 2: Increased O2 Day 3-5, Discharged requirements; HFNC Home 45/FiO2 100% 15L NRB Remdesivir and dexamethasone
Acknowledgments • ID Colleagues Drs Laura Beauchamps, Jovanna Bertran, Foluaskin Ayoade, Stephen Morris, Yoichiro Natori, Jacques Simkins, Shweta Anjan • University or Miami Pathology/Genetics/Cancer Center Colleagues Drs. Merce Jorda (Chair), Emmanuel Thomas, Sion Williams (Cancer Center), Yi Zhou, Anthony Griswold (Genetics), Jacob McCauley (Genetics), Octavio Martinez, Ranjini Valiathan, Ms. Yamina Caratini • JHS Antimicrobial Stewardship and Pharmacy Teams Venessa Goodnow, Ennie Cano, Ana Vega, Kailyn Deronde, Meshell Maxam, Christine Vu, Julio Simon, Renata Boatright, Veronica Salazar. • JHS Infection Prevention Team Kathleen Sposato, Maribel Ruiz, Adriana Jimenez, Javier Cardozo, Regina McDade, Natalia Fadul, Jolie Dobson, Paula Weisberg, Regina Williams, Kelley Manzanillo, Christopher Christy, Delia Roberts, Olga Orozco, Doreen Amarsingh • JHS Microbiology Lab Team • Huy Dingh, Biaggio di Pascale, Clara Prado, Sallie Wright, Katiuska Parra, Joanna Danton • JHS Information and Technology • Dr. Alina Brebene, Dr. Joseph Zeitouini, Jermaine Allen, Donna Benjamin
Thank you @liliabbo
Updates on COVID-19 Vaccine breakthrough infections: Clinical perspective from Miami Shweta Anjan, MD Assistant Professor of Clinical Medicine Division of Infectious Diseases University of Miami Miller School of Medicine
Disclosure • No conflicts of interest to disclose
Vaccine breakthrough infections Immunocompetent Immunocompromised N=9 N=18
Immunocompetent Demographics Co-morbidities • Mean Age: 70 years (58 - 89) • 67% HTN • 67% Male • 89% BMI >25 • 78% Hispanic • 22% DM Median time from vaccine to COVID diagnosis: 67 days (9-115) (56% mRNA, 44% Ad26.COV2.S) All required hospital admission (67% ICU, 33% COVID-19 Ward) Management Outcomes • Remdesivir + dexamethasone 55% • 89% recovered and discharged home • Convalescent plasma, tocilizumab 11% • 11% (n=1) mortality • Supportive care 11%
Immunocompromised: Solid organ transplant recipients • Antibody response lower than general population • Severe immunosuppression has been linked to Chronic COVID-19 and Virus variants 1. Boyarsky BJ et al. Antibody Response to 2-Dose SARS-CoV-2 mRNA Vaccine Series in Solid Organ Transplant Recipients. JAMA. 2021;325(21):2204–2206. 2. 2. Abbasi J. Researchers Tie Severe Immunosuppression to Chronic COVID-19 and Virus Variants. JAMA. 2021;325(20):2033–2035.
Immunocompromised: Solid organ transplant recipients • As of April 30, 2021, 2957 SOTR have been vaccinated →18 cases (breakthrough rate 0.60%) • 83% were fully vaccinated • Demographics • 58 (41 – 81) years • 50% Female • 72% Hispanic ethnicity • 50% →exposed to an unvaccinated family member with COVID-19
TYPE OF ORGAN TRANSPLANT Kidney Liver Lung Combined • Time from transplant to first dose of the vaccine 17% →26 (range 2 - 90) months – 3/18 within 6 months of transplant 5% • Time from vaccine to diagnosis →25 days (range, 4 11% – 96) 67%
Clinical Course Hospital admission Outpatient 56% 44% Remdesivir 100% Casirivimab/Imdevimab High dose steroids 90% 39% Total plasma exchange 30% 28% admitted within 28 days of receiving MAB Recovered and Death Still hospitalized for non-COVID-19 care discharged 10% (n=1) 10% home All Recovered 80%
In Summary • Severe COVID-19 and mortality can occur in vaccine breakthrough cases • Encourage patients to seek medical care early while they may qualify for MAB • Immunocompromised individuals should continue wearing a mask • Vaccine breakthrough data comparing available vaccines (mRNA, viral vector and adjuvanted protein platforms) are needed • Vaccine protocols may need to be tailored by State, population and predominant variant
Questions? sxa835@med.miami.edu @shwetanjan
SARS-CoV-2 gene variant trends from patient and student samples in Miami-Dade County, Florida David Andrews, MD Associate Professor of Clinical Pathology University of Miami Miller School of Medicine Vice-chief, Pathology, Jackson Health System Hospitals CLIA Lab Director, Jackson Memorial, Jackson North, Jackson South Hospitals June 5, 2021
Disclosure • No conflicts of interest to disclose
Study Design Non-HSRO/deidentified samples for Surveillance effort • Beginning mid-January 2021, residual clinical samples were retrieved from the lab after Positive SARS-CoV-2 molecular results obtained. • Samples initially screened in Pathology by qPCR with the TaqPath (TaqPath COVID-19 PCR, Thermo Fisher Scientific) assay to detect the B.1.1.7 UK Variant as manifested by the S-Gene target failure (SGTF) • Sequencing methods developed in our Cancer Center (Sylvester Comprehensive Cancer Center) Oncogenomics Core facility, where the NEB Biolabs ARTIC method of multiplexed amplicon-based whole viral genome sequencing was implemented on the Illumina NovaSeq platform. Program overseen by Dr. Sion Williams. • Bioinformatics pipeline was handled by Dr. Anthony Griswold in our UM Genetics Institute (Hussman Institute for Human Genomics)
Sample sources – weekly collections Jackson Memorial Hospital Jackson North Medical Center Jackson South Medical Center Ambulatory Urgent Care Centers UHealth Tower (University of Miami Hospital) Sylvester Cancer Center Undergraduate Students Active SARS-CoV-2 screening program
Overall lineage trends: Varied & Diverse, like Miami! PANGO Lineages
B.1.1.7 trending down
Increasing prevalence Jan -> May 2021 Variants of Concern, Variants of Interest, emerging Variants of interest. B.1.427/29 “CA” VOC B.1.526 “NY” VOI VOC, VOI, emerging VOI, other than B.1.1.7 P.1 “Brazil (Manaus)” VOC B.1.1.7 “UK” VOC March 2021 (N = 138) April 2021 (N = 162) May 2021 (N = 146) Feb* 2021 (N = 105) *includes late Jan samples PANGO LINEAGE
May 2021 NGS (SARS-Cov-2) May 2021 NGS summary: Approximately 88% of samples sequenced revealed a PANGO lineage associated with a VOC, VOI, or an emerging variant of interest.
Feb –> early May VOC/VOI expansion Conclusion: Despite significant expansion of VOC/VOI, case numbers are falling in association with increased vaccination rate. The data suggests vaccines provide good protection. Percent vaccinated Miami-Dade County graphs retrieved 6-4-2021 from covidactnow.org (source data from Florida Dept. of Health)
Quote: Vaccine evaluations against new variants will be more challenging going forward as data from randomized, placebo-controlled clinical trials become less common owing to enhanced availability of vaccines. A global scientific agenda that encompasses extensive genomic surveillance, detailed “correlate of protection” evaluations, and robust post-introduction surveillance and sequencing is necessary to measure the effect of new and current vaccines against SARS-CoV-2 variants. NEJM 384;20 May 20, 2021
Thank you! dandrews@miami.edu Acknowledgments: UM: Dr. Merce Jorda (Pathology chair) and Dr. Stephen Nimer (Cancer Center director) JHS: Dr. Peter Paige, CMO
Q&A and Discussion 43
Links and Resources ▪ Slide 5 - CDC Science Brief: COVID-19 Vaccines and Vaccinationwww.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully- vaccinated-people.html ▪ Slide 37 – Calculator https://www.medcalc.org/calc/comparison_of_proportions.php 44
45 Specialty Society Collaborators An online community bringing together information and opportunities for discussion on latest research, guidelines, tools and resources from a American Academy of Family Physicians variety of medical subspecialties around the world. American Academy of Pediatrics American College of Emergency Physicians American College of Physicians American Geriatrics Society American Thoracic Society Pediatric Infectious Diseases Society Society for Critical Care Medicine Society for Healthcare Epidemiology of America Society of Hospital Medicine Society of Infectious Diseases Pharmacists www.COVID19LearningNetwork.org @RealTimeCOVID19 #RealTimeCOVID19
CDC-IDSA Partnership: Clinical Management Call Support FOR WHOM? - Clinicians who have questions about the clinical management of COVID-19 WHAT? - Calls from clinicians will be triaged by CDC to a group of IDSA volunteer clinicians for peer-to-peer support HOW? - Clinicians may call the main CDC information line at 800- CDC-INFO (800-232-4636) - To submit your question in writing, go to www.cdc.gov/cdc-info and click on Contact Form cdc.gov/coronavirus
idweek.org Virtual Conference Save the Date Sept. 29 – Oct. 3, 2021 Important Dates: • Registration is Open Attend, Learn & Collaborate. • Abstract Submission Deadline – June 9 Advancing Science, Improving Care • Case Submission Deadline – June 9
We want to hear from you! Please complete the post-call survey. Starting in June the calls will be held the Continue the twice a month: conversation on Twitter Next Call Saturday, June 19 @RealTimeCOVID19 Topic: Myocarditis #RealTimeCOVID19 A recording of this call will be posted at www.idsociety.org/cliniciancalls -- library of all past calls available -- Contact Us: Dana Wollins (dwollins@idsociety.org) Deirdre Lewis (dlewis@idsociety.org) 48
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